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( Jeong Heo ),( Sang Hoon Ahn ),( Young Oh Kweon ),( Byung Ho Kim ),( Henry Ly Chan ),( Andrzej Horban ),( Suchat Wongcharatrawee ),( Cyril Llamoso ),( Kwan Sik Lee ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.-
Background: Unlike the combination of adefovir (ADV) and lamivudine (LVD), currently recommended for treatment of LVD-resistant chronic hepatitis B, both components of an entecavir (ETV)+ADV combination have antiviral activity against LVD-resistant HBV. ETV+ADV may therefore provide antiviral synergy in this challenging population. Methods: In this open-label, multi-center study, 416 HBeAg(+) CHB patients with LVD-resistant HBV were randomized 1:1:1 to receive ETV+ADV (1.0 mg+10 mg), ADV+LDV (10 mg+100 mg) or ETV (1.0 mg) once-daily for 100 weeks. The primary efficacy endpoint was the proportion with HBV DNA <50 IU/mL at Week 48; comparing ETV+ADV to ADV+LVD and ETV monotherapy using the 2-stage Hochberg procedure. At Week 96, the key efficacy endpoint was the difference in proportion <50 IU/ml for ETV+ADV vs ADV+LDV. Subjects who discontinued prior to each analysis were considered failures (NC=F). Results: A total of 415 patients were dosed (76% Korean, 67% male, mean age 44 years). Mean baseline HBV-DNA was 7.4 log10 IU/mL (86% Subtype C, 7% A, 4% B, 3% D, <1% H). At Week 48, proportions <50 IU/mL for ETV+ADV (n=138), ADV+LVD (n=137) and ETV (n=140) were 25.4%, 19.7% and 16.4%, respectively (p=NS). At Week 96, ETV+ADV vs ADV+LDV for <50 IU/mL was 43.5% vs. 28.5% (Difference 15.0%; p=0.0095). Other endpoints are shown in the table below. Conclusions: With 96 weeks of treatment, the antiviral efficacy of ETV+ADV was superior to LVD+ADV. All treatments were well tolerated and had comparable safety profiles.
( Jeong Heo ),( Sang Hoon Ahn ),( Young Oh Kweon ),( Byung Ho Kim ),( Henry Ly Chan ),( Andrzej Horban ),( Suchat Wongcharatrawee ),( Cyril Llamoso ),( Kwan Sik Lee ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.1
Background: Unlike the combination of adefovir (ADV) and lamivudine (LVD), currently recommended for treatment of LVD-resistant chronic hepatitis B, both components of an entecavir (ETV)+ADV combination have antiviral activity against LVD-resistant HBV. ETV+ADV may therefore provide antiviral synergy in this challenging population. Methods: In this open-label, multi-center study, 416 HBeAg(+) CHB patients with LVD-resistant HBV were randomized 1:1:1 to receive ETV+ADV (1.0 mg+10 mg), ADV+LDV (10 mg+100 mg) or ETV (1.0 mg) once-daily for 100 weeks. The primary efficacy endpoint was the proportion with HBV DNA <50 IU/mL at Week 48; comparing ETV+ADV to ADV+LVD and ETV monotherapy using the 2-stage Hochberg procedure. At Week 96, the key efficacy endpoint was the difference in proportion <50 IU/ml for ETV+ADV vs ADV+LDV. Subjects who discontinued prior to each analysis were considered failures (NC=F). Results: A total of 415 patients were dosed (76% Korean, 67% male, mean age 44 years). Mean baseline HBV-DNA was 7.4 log10 IU/mL (86% Subtype C, 7% A, 4% B, 3% D, <1% H). At Week 48, proportions <50 IU/mL for ETV+ADV (n=138), ADV+LVD (n=137) and ETV (n=140) were 25.4%, 19.7% and 16.4%, respectively (p=NS). At Week 96, ETV+ADV vs ADV+LDV for <50 IU/mL was 43.5% vs. 28.5% (Difference 15.0%; p=0.0095). Other endpoints are shown in the table below. Conclusions: With 96 weeks of treatment, the antiviral efficacy of ETV+ADV was superior to LVD+ADV. All treatments were well tolerated and had comparable safety profiles.